Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

NCT ID: NCT05956990

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-01

Brief Summary

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A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention

Detailed Description

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Conditions

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Colorectal Cancer Survivor Rehabilitation Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients were randomly assigned to the rehabilitation group and control group by online randomization software
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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multidimensional rehabilitation group

The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior.

Group Type EXPERIMENTAL

multidimensional rehabilitation

Intervention Type BEHAVIORAL

Multidimensional lifestyle interventions

Control group

The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multidimensional rehabilitation

Multidimensional lifestyle interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
* Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
* PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
* Be able to walk without assistance;
* Conscious and intellectually normal;
* Voluntarily participate in the research of this topic and provide the consent form for medical record review;
* Mobile phones can be used.

Exclusion Criteria

* Patients with multiple cancers.
* Tumors not completely resected.
* Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
* Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
* In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
* Patients with special dietary requirements.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

Qu Shen

OTHER

Sponsor Role lead

Responsible Party

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Qu Shen

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Qu Shen

Role: CONTACT

+865922189613

References

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Hu Y, Peng H, Su G, Chen B, Yang Z, Ye Y, Zhou B, Lin S, Deng H, Zhang J, Xie Y, He H, Ruan Z, Shen Q. Effect of a metaverse multimodal rehabilitation intervention on quality of life and fear of recurrence in patients with colorectal cancer survivors: A randomized controlled study protocol. Digit Health. 2024 Nov 18;10:20552076241295542. doi: 10.1177/20552076241295542. eCollection 2024 Jan-Dec.

Reference Type DERIVED
PMID: 39564355 (View on PubMed)

Other Identifiers

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XiamenUYHu

Identifier Type: -

Identifier Source: org_study_id

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